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UDI: How to Prepare for ANVISA’s Regulatory Changes in Medical Devices

The deadline for UDI to comply with ANVISA is approaching With the publication of RDC (Collegiate Board Resolution) No. 591/2021, ANVISA established the requirement to identify medical devices in its regulated products using the UDI (Unique Device Identification) system. The UDI is the set of [...]

Transforming the Future: Amoveri Group and Help Medical Join Forces

Impact Acquisition: Amoveri Group Acquires Help Medical We are pleased to share news that will certainly positively impact our partnership: Amoveri Group has recently concluded the acquisition of Help Medical, a company owned by Passarini Group. This notable transaction not only marks an important moment [...]

New RDC 283 that Revokes RDC 116 Fundamental for INMETRO

New Anvisa Technical Standards: Ensuring the Quality and Safety of Medical Devices On March 8, the National Health Surveillance Agency (Anvisa) announced the publication of the updated list of Technical Standards applicable to the certification of conformity of equipment subject to the Health Surveillance regime. [...]

Celebrating 15 Years of Innovation and Excellence with Passarini Group!

Celebrating 15 Years of Innovation and Excellence with Passarini Group! It is with great enthusiasm that we share with you an extraordinary journey of 15 years of innovation, excellence, and success with Passarini Group! Throughout this trajectory, we have proudly served our friends, clients, and [...]

Anvisa approves Strategic Plan for the 2024-2027 cycle

Anvisa approves Strategic Plan for the 2024-2027 cycle The National Health Surveillance Agency (Anvisa) is the regulatory body responsible for health regulation in Brazil, working to protect and promote the health of the population. To fulfill its mission, Anvisa develops and implements strategic plans that [...]

RDC 830/2023 New Regulations for Medical Devices

RDC 830/2023 comes into force from june 1, 2024 RDC 830/2023, provides for the risk classification notification and registration regimes, and labeling requirements and instructions for in vitro diagnosis, including their instruments, comes into force from the 1st of june 2024. With the publication of [...]


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